Course 3: Pharmacovigilance Inspections Part 1: Readiness, Conducting, Findings, and Report-Outs
Richard Abate, MS, RPh
- Pharmacologist\Consumer Safety Officer
- FDA, United States
Richard Abate serves as the Postmarketing Adverse Drug Experience (PADE) Compliance Team Leader in CDER's Office of Compliance. Rick joined FDA in 2006 as a Safety Evaluator in CDER's Office of Surveillance and Epidemiology and moved to Office of Compliance in 2013. Rick obtained a BS in Pharmacy from the University of Maryland and a MS in Pharmacy Practice from the University of North Carolina.
Marcia Gelber, PharmD, RPh
- Food and Drug Administration, United States
Marcia Gelber joined FDA in 2009 as a Consumer Safety Officer in CDER’s Office of Compliance, Office of Scientific Investigations where she is responsible for planning and evaluating drug safety inspections and serves as a consultant to FDA field personnel on problems encountered during inspections. Prior to joining FDA, Marcia worked in the pharmaceutical industry for over 25 years. She is a registered pharmacist and graduate of the University of the Sciences in Philadelphia, PA. Marcia enjoys teaching drug safety and pharmacovigilance because safe medications improve lives.
Shiferaw Kibriye, PharmD
- Medical Quality Assurance. Head of Inspection Management and GLP QA
- Pfizer Inc., United States
Shiferaw is currently the Head of Inspection Management, within Medical Quality Assurance at Pfizer. Previous to his current role, he was an Executive Director, Therapeutic Area Head within Safety Evaluation and Reporting within the Worldwide Safety organization at Pfizer. Previous to these roles, Shiferaw worked in the Global Investigator Initiated Research (IIR) group as a Director/Team Leader in charge of all IIRs in the Specialty Care and Emerging Markets Business Units.
- Principal Consultant
- NDA Regulatory Science Ltd, United Kingdom
Helen Powell has over 30 years’ experience in the pharmaceutical industry in large pharma, CRO and consultancy sectors, the majority of time in QA conducting audits in GCP, Pharmacovigilance and auditing of corporate legal risks. Prior to becoming an auditor, Helen worked in laboratory research, as a sales representative and a Clinical Research Associate. She has managed global audit teams across the USA, Asia Pacific and Europe, as well as facilitating Pharmacovigilance and GCP inspections in these territories.
Michael Richardson, MD, FFPM
- International GPV&E and EU QPPV, Qualified Person for Pharmacovigilance
- Bristol-Myers Squibb, United Kingdom
Michael Richardson has many years of global management experience in research based life Sciences companies. He has worked in major multinational companies’ across the globe both at a Regional management level and heading up Research and Development in Asia. Currently Head of Bristol Myers Squibb’s Pharmacovigilance Function. Prior to this role he headed BMS and Eli Lilly’s Development and Medical Organization across Asia Pacific. Before joining Lilly he worked in a joint venture in Japan, Fujisawa-Fisons setting up their development and quality control organisations and prior to that with Organon laboratories in the UK as Medical Director.